CORTRAK 2 EAS Electromagnetic Transmitting Stylet and CORFLO Feeding Tube 20-9431TRAK2ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10815149023943), received between May 11, 2017 and Aug 18, 2017 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2017Break; Disconnection; Migration or Expulsion of Device; Break; Disconnection; Migration or Expulsion of Device

  A HALYARD HEALTH MAUDE DATABASE RECONCILIATION WAS PERFORMED ON 25-JUL-2017 AND IDENTIFIED MAUDE REPORT NUMBER (B)(4) AS NOT IN HALYARD HEALTH'S INTERNAL SYSTEMS. THE REPORT STATED: "ON A ROUTINE CHEST X-RAY, THE TUBE WAS NOTED TO BE DISCONNECTED INSIDE OF THE PT., NOTED AS A "FRACTURE. " A FOLLOWING CT REVEALED THAT THE FEEDING TUBE HAD FRACTURED AND THAT THE DISTAL PORTION OF THE TUBE HAD MIGRATED INTO THE SMALL BOWEL." NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6804180 ↗
• InjuryMay 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MEDWATCH REPORT WAS RECEIVED ON VIA MEDWATCH # MW5068628. THE REPORT STATED,"NURSE WAS FOLLOWING ORDERS TO PLACE ORO-GASTRIC FEEDING TUBE. AFTER PLACEMENT OF TUBE, THE PLACEMENT WAS BEING CONFIRMED WITH X-RAY WHICH SHOWED FEEDING TUBE NOT IN STOMACH, FT WAS WITHDRAWN AND RE-ATTEMPTED. APPROXIMATELY 30 MINUTES LATER IT WAS CLINICALLY APPARENT THAT THE PATIENT HAD A PNEUMOTHORAX REQUIRING PLACEMENT OF CHEST TUBE." ADDITIONAL INFORMATION RECEIVED STATED THAT ADEQUATE TRAINING WAS NOT PROVIDED AND THE ISSUE COULD BE DUE TO USER ERROR. ADDITIONAL INFORMATION RECEIVED ON 04-MAY-2017 FROM THE HOSPITAL'S RISK MANAGEMENT REPRESENTATIVE STATED THAT AN X-RAY CONFIRMED THE TUBE WAS NOT IN THE STOMACH. THE NASOGASTRIC (NG) TUBE WAS REPLACED AND CONFIRMED IN TO BE IN THE STOMACH. UPON FOLLOW-UP, THE PATIENT DEVELOPED PNEUMOTHORAX. IT WAS NOTED THAT THE HOSPITAL WAS NOT USING THE NG TUBES PROPERLY. THE NG TUBE WAS USED WITHOUT THE USE OF THE CORTRAK DEVICE/TRACKING. THE DEVICE WAS USED BY NURSE THAT DID NOT HAVE APPROPRIATE TRAINING.

  Patient problems: Pneumothorax

  MAUDE report 6562915 ↗
• InjuryMay 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MEDWATCH REPORT WAS RECEIVED VIA MEDWATCH # MW5068629. THE REPORT STATED: "NURSLNG RECEIVED ORDER TO PLACE ORO-GASTRIC FEEDING TUBE. POST PLACEMENT, FT CONFIRMED BY CHEST X-RAY TO BE IN STOMACH. SHORT TIME THEREAFTER, PT BEGAN TO GO INTO RESPIRATORY FAILURE AND WAS FOUND TO HAVE PNEUMOTHORAX REQUIRING PLACEMENT OF CHEST TUBE." ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2017 FROM THE HOSPITAL'S RISK MANAGEMENT REPRESENTATIVE STATED THAT AN X-RAY CONFIRMED THE TUBE WAS IN THE PATIENT'S STOMACH, AND LATER DEVELOPED PNEUMOTHORAX. IT WAS NOTED THAT THE HOSPITAL WAS NOT USING THE NASOGASTRIC (NG) TUBES PROPERLY. THE NG TUBE WAS USED WITHOUT THE USE OF THE CORTRAK DEVICE/TRACKING. THE DEVICE WAS USED BY NURSE THAT DID NOT HAVE APPROPRIATE TRAINING.

  Patient problems: Pneumothorax

  MAUDE report 6561689 ↗
• InjuryMay 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MEDWATCH REPORT WAS VIA MW5068647 WHICH STATED: "ORDER RECEIVED BY NURSING TO PLACE FEEDING TUBE. AFTER PLACEMENT IT BECAME CLINICALLY APPARENT THAT THE PATIENT WAS SUFFERING PNEUMOTHORAX REQUIRING CHEST TUBE PLACEMENT." ADDITIONAL INFORMATION RECEIVED ON 04-MAY-2017 FROM THE HOSPITAL'S RISK MANAGEMENT REPRESENTATIVE STATED THAT AN X-RAY CONFIRMED THE TUBE WAS IN THE PATIENT'S STOMACH, AND LATER DEVELOPED PNEUMOTHORAX. IT WAS NOTED THAT THE HOSPITAL WAS NOT USING THE NASOGASTRIC (NG) TUBES PROPERLY. THE NG TUBE WAS USED WITHOUT THE USE OF THE CORTRAK DEVICE/TRACKING. THE DEVICE WAS USED BY NURSE THAT DID NOT HAVE APPROPRIATE TRAINING.

  Patient problems: Pneumothorax

  MAUDE report 6561679 ↗
• MalfunctionMay 11, 2017Break; Material Discolored; Material Frayed; Break; Material Discolored; Material Frayed

  IT WAS REPORTED THAT A PATIENT, WHO HAS BEEN IN THE HOSPITAL "FOR A WHILE," PULLED OUT AN NASOGASTRIC (NG) TUBE, AND THE 1-INCH END OF IT WAS BLACK AND FRAYED. DURING STAFF OBSERVATION, IT WAS NOTED THAT A PORTION OF THE TUBE WAS MISSING AND RETAINED INSIDE THE PATIENT. THE PATIENT HAD AN ENDOSCOPY PROCEDURE TO REMOVE THE RETAINED TUBE. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 6559897 ↗